Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regulatory’ Requirements - McDermott Will & Emery

Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regulatory’ Requirements

Overview


Paul Hughes is quoted in a Pink Sheet article about Vanda saying that the Food and Drug Administration (FDA) improperly requires it to disprove all alleged deficiencies in its Hetlioz application for jet lag.